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The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates.
Intended areas of use:
• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
• During transfer of ventilated patients within the hospital
The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-C3 is designed for adult, pediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation.
The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-C3:
• Therapy type: HiFlowO2

The provided document is a 510(k) summary for the Hamilton-C3 ventilator, seeking to add a "HiFlowO2" therapy type. This document does not describe acceptance criteria for a device's performance in a diagnostic or predictive capacity, nor does it detail a study that proves a device meets such criteria in the way a clinical trial for an AI diagnostic might. Instead, it describes compliance with regulatory standards and a bench test to show equivalence for a new feature.

Therefore, many of the requested elements for describing acceptance criteria and a study (like sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not available within this regulatory submission.

However, I can extract information related to the device's technical specifications and how the new feature was evaluated for substantial equivalence.

Here's the closest representation of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the HiFlowO2 feature in a quantitative form with specific thresholds (e.g., "accuracy > X%"). Instead, the acceptance criterion for the new HiFlowO2 therapy type is substantial equivalence to the reference device (HAMILTON-G5) regarding its flow and oxygen values.

• Neonatal: HAMILTON-C3 (2 to 12 l/min) vs. HAMILTON-G5 (1 to 12 l/min) — Similar
• Adult/Pediatric: HAMILTON-C3 (2 to 60 l/min) vs. HAMILTON-G5 (1 to 60 l/min) — Similar

HiFlowO2 Default Settings (Comparison to HAMILTON-G5):

• Flow Adult/Pediatric: HAMILTON-C3 (15 l/min) vs. HAMILTON-G5 (15 l/min) — Same
• Flow Neonatal: HAMILTON-C3 (2 l/min) vs. HAMILTON-G5 (1 l/min) — Similar
• Oxygen Adult/Pediatric: HAMILTON-C3 (50%) vs. HAMILTON-G5 (50%) — Same
• Oxygen Neonatal: HAMILTON-C3 (40%) vs. HAMILTON-G5 (40%) — Same

"The data provided from this test was shown to be substantially equivalent to the legally marketed predicate device [referring to the reference device for HiFlowO2]." |

The "predicate device" and "reference device" mentioned in the document are already legally marketed and cleared devices. The Hamilton-C3, with the new HiFlowO2 feature, is being compared to these existing devices to demonstrate that it is "substantially equivalent" and therefore safe and effective.

2. Sample size used for the test set and the data provenance

• Sample size: Not specified in terms of patient or case numbers. The evaluation of the HiFlowO2 feature was conducted via a bench test. Bench tests typically involve testing the physical device's performance under simulated conditions, not using patient data.
• Data provenance: Not applicable in the context of patient data, as the testing was non-clinical (bench testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. The ground truth for a bench test typically involves calibrated measurement equipment and engineering standards, not expert human interpretation of medical cases.

4. Adjudication method for the test set

• Not applicable. This type of testing does not involve human adjudication of medical findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a submission for a ventilator with a new therapy type, not an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is for a medical device (ventilator), not an algorithm that performs a diagnostic or predictive function. The "study" mentioned is a bench test to verify the physical performance of the ventilator with its new feature.

7. The type of ground truth used

• For the bench test of the HiFlowO2 feature: The "ground truth" would be the measured physical outputs (flow rates and oxygen concentrations) from the Hamilton-C3 device, compared against the specifications and expected performance based on the reference device (HAMILTON-G5) and engineering principles. This is not medical ground truth like pathology or expert consensus.
• For software validation and overall device compliance: The "ground truth" is adherence to established international standards (e.g., IEC 60601 series, ISO 80601 series, IEC 62304) and internal design specifications.

8. The sample size for the training set

• Not applicable. There is no AI model or algorithm being "trained" in the context of this regulatory submission based on the provided text.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set.

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The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates.

Intended areas of use:

· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room

· During transfer of ventilated patients within the hospital

The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-C3 is designed for adult, paediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation.

The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-C3:

• The following two new ventilation modes for adult / pediatric patient group: ● (S)CMV and SIMV
• SpO2 monitoring option

This section describes the acceptance criteria and the study proving the device meets those criteria, based on the provided text.

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The provided text focuses on device performance testing against regulatory standards and software validation. It mentions "waveform performance testing" for the new ventilation modes. However, it does not specify the sample size for any test sets used in performance testing, nor does it detail the data provenance (e.g., country of origin, retrospective/prospective nature of data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided in the document. The testing described is primarily technical compliance and performance against established engineering standards and validated software functionality, rather than a clinical study requiring expert ground truth for interpretation of outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided. The text describes bench testing and software validation, not a study design involving adjudication of human interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the provided text. The device is a ventilator, and the testing described is related to its technical performance and safety, not a diagnostic or interpretive AI system that human readers would use.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The document describes "Software Design and Validation" processes, "bench testing of the device," and "waveform performance testing" for the new ventilation modes. These types of tests are inherently "standalone" in that they evaluate the device's algorithmic and mechanical performance directly against engineering specifications and expected outputs, without direct human intervention as part of the core performance measurement, other than operating the test equipment. So, yes, standalone algorithm performance was assessed though not explicitly called out as such.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's technical performance and safety is derived from the international and national standards and guidelines listed (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-12). For the new ventilation modes, "waveform performance testing" was conducted, implying that the ground truth for correct operation were the expected waveform characteristics and parameters as defined by the ventilator's design specifications and the algorithms derived from the predicate HAMILTON-G5.

8. The sample size for the training set:

A "training set" is typically associated with machine learning or artificial intelligence models. As this document describes a medical device (ventilator) and its compliance with technical standards and software validation, there is no mention of a training set in the context of machine learning. The "training" for such a device would refer to its design, development, and engineering phases.

9. How the ground truth for the training set was established:

Since there is no mention of a training set in the context of machine learning, this question is not applicable. The "ground truth" for the device's design and functionality is established through engineering principles, medical device regulatory requirements, and the functionalities of predicate devices.

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The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants, and neonates.

Intended areas of use:

• In the intensive care ward or in the recovery room.
• During transfer of ventilated patients within the hospital.

The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-C3 has been designed to ventilate adult and pediatric patients in the critical care environment. With optional support, the HAMILTON-C3 is also able to ventilate infants and neonates. The HAMILTON-C3 ventilator uses the same graphical user interface (GUI) used by the predicate HAMILTON-C2, which features a touchscreen "Ventilation Cockpit". This provides the exact information that the user needs and helps focus on what is important. In addition, the HAMILTON-C3 includes the ASV ventilation-mode, which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.
The HAMILTON-C3 has been designed with built-in batteries and a turbine thereby giving the user maximum independence and flexibility to accompany a patient everywhere. The HAMIL-TON-C3 offers the same ventilation modes as the HAMILTON-C2, which provides for both full and partial ventilatory support.

1. The HAMILTON-C3 offers all the conventional modes, as well as advanced invasive and non-invasive ventilation modes: ASV, (S)CMV+, SIMV+, PCV+, SPONT, APRV, DuoPAP, NIV, NIV-ST, nCPAP-PS, PSIMV+, and PSIMV+ with IntelliSync.
2. All 41 monitoring parameters can be trended over 1, 6, 12, 24, and 72 hours.
3. The ability to turn off the Apnea alarm in the nCPAP-PS mode.
4. The HAMILTON-C3 includes a 12.1" wide-screen monitor.

The Hamilton-C3 is a continuous ventilator. The provided text outlines its characteristics, intended use, and a comparison with a predicate device and other FDA-cleared ventilators. However, it does not include detailed acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device with performance metrics like sensitivity, specificity, or F1-score.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance. The "acceptance criteria" discussed are primarily related to safety, effectiveness, and adherence to recognized standards, rather than specific performance metrics for a novel diagnostic function.

Here's a breakdown based on the information provided, and where information is not present:

1. Table of acceptance criteria and the reported device performance

Based on the document, "acceptance criteria" are inferred from the demonstration of substantial equivalence and adherence to recognized standards. The "reported device performance" is largely presented as meeting the same functional capabilities as the predicate device (HAMILTON-C2) and adhering to various medical device standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable in the traditional sense for this submission type. This is a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" of patient data to evaluate a diagnostic algorithm's performance. The "testing" referred to is non-clinical verification and validation of the device's functionality and adherence to standards. There is no mention of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. As per point 2, there is no "test set" with ground truth in the context of diagnostic performance presented in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This document describes a continuous ventilator, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a medical device (ventilator), not a standalone algorithm. While it contains software, the evaluation in this document focuses on the integrated system's safety and effectiveness and its equivalence to a predicate device, not on the performance of a standalone algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. As per point 2, there is no "test set" requiring ground truth for diagnostic performance evaluation. The "ground truth" for the device's functionality is its design specifications and compliance with recognized standards.

8. The sample size for the training set

• Not Applicable. This document does not describe the development or evaluation of an AI/ML algorithm that would require a "training set" of data.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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